Sanofi and Regeneron, weeks after unveiling a second late-stage win for Dupixent in prurigo nodularis, have bagged the first U.S. approval specifically aimed at the debilitating skin disease.
The FDA on Wednesday blessed the partners' immunology star Dupixent, also known as dupilumab, to treat adults with the chronic type 2 inflammatory condition, which Sanofi and Regeneron assert takes “one of the highest” tolls on patient quality of life among inflammatory skin diseases.
Prurigo nodularis—which Sanofi and Regeneron estimate affects about 75,000 adults in the U.S.—is characterized by “intense, persistent” itch accompanied by thick skin lesions, called nodules, that can cover most of the body, the companies explained in a release.
Further, it’s estimated that there are about 145,000 adults with prurigo nodularis in the U.S. and Europe combined, while “many more” people worldwide struggle to control their disease with the current standard of treatment—topical steroids—which can have severe side effects when used over long stretches of time, a Sanofi spokesperson told Fierce Pharma earlier this month.
While prurigo nodularis may not have the same notoriety as atopic dermatitis—or eczema—“in terms of dermatological conditions, it actually has one of the greatest impacts on patients’ quality of life,” Bola Akinlade, M.D., senior vice president and therapeutic area head of immunology and inflammation at Regeneron, added in a recent interview with Fierce.
The disease is often misunderstood, too, Naimish Patel, M.D., Sanofi’s SVP and global development head for immunology and inflammation, said in the interview.
Because treatment has long been relegated to subpar steroids, people with prurigo nodularis often contend with “unrelenting itch all the time,” Patel said, which physicians sometimes assume is just in the patient’s head.
The FDA based its go-ahead on data from two phase 3 trials, dubbed PRIME and PRIME2.
In PRIME and Prime2, roughly three times as many Dupixent patients saw a clinically meaningful reduction in itch from baseline after 24 weeks of treatment versus those on placebo.
Sanofi and Regeneron’s studies also found that more than twice as many Dupixent patients (48% and 45%) achieved clear or almost clear skin at 24 weeks compared to those given placebo (18% and 16%).
Safety was generally on par with Dupixent’s known profile in dermatology, Sanofi and Regeneron pointed out.
Prurigo nodularis isn’t the first—nor is it likely the last—type 2 inflammatory disease Dupixent will tussle with. Sanofi and Regeneron are also pitting their IL-4/IL-13 inhibitor against skin conditions like spontaneous urticaria and bullous pemphigoid.
Dupixent has been on an approval spree this year, racking up wins in atopic dermatitis and in severe asthma including in younger patients along with an approval as the first medication specifically indicated for eosinophilic esophagitis.
During the interview with Fierce earlier this month, Regeneron’s Akinlade and Sanofi’s Patel echoed the common refrain from the partners that Dupixent is just at the beginning of its journey.
“Clearly, Dupixent remains the No. 1 driver of our growth story,” Sanofi’s chief executive Paul Hudson said on the company’s recent second-quarter earnings call. For the second three months of 2022, Dupixent pulled down sales of 1.96 billion euros, growing 43.4% at constant currencies, Sanofi said at the time.
In fact, Sanofi is so abuzz about Dupixent’s potential it recently upgraded its peak sales target for the antibody from 10 billion euros to more than 13 billion euros. Upcoming readouts in chronic obstructive pulmonary disease could drive that sales peak even higher.
Editor's note: This story has been updated to correct timing and add additional details from Prime and Prime2.